Dr Ulli Backofen
Boehringer Ingelheim
Referent:innen
Dr. Thomas Fürst
Boehringer Ingelheim
Dr Josef Hofer
exdra
Dr Cornelia Nopitsch-Mai
formerly Quality Assessor
Dr. Bettina Pahlen
Quality x Pharma Consulting
Dr Thomas Uhlich
Bayer
Dr Heiko Brunner
Hamburg
Book "Setting Specifications and Acceptance Criteria" and "Stability Testing for Drug Substances and Drug Products" together and save € 400!
Zielgruppe
Setting Specifications and Acceptance Criteria:
- Personnel and specialists from QA, QC and Regulatory Affairs departments in the API and pharmaceutical industry
- Personnel from contract development and manufacturing organisations
- Representatives of EU inspectorates and regulatory authorities
Stability Testing for Drug Substances and Drug Products:
- Personnel and specialists from QA, QC and Regulatory Affairs departments in the API and pharmaceutical industry
- Personnel from contract development and manufacturing organisations
- Representatives of EU inspectorates and regulatory authorities
Zielsetzung
Setting Specifications and Acceptance Criteria:
In the development of new pharmaceutical products, it is a great challenge to establish meaningful and reasonable specifications, which are scientifically sound and appropriate for APIs (chemical and biological drug substances), excipients and drug products.
This course covers all aspects of specifications for Active Pharmaceutical Ingredients (APIs = Drug Substances), biological substances and pharmaceutical drug products from an analytical and a registration perspective.
In the workshops the participants will elaborate specifications
- for drug substance and drug product based on different case studies,
- specifications of biotechnological drug substances / drug products – general part
- specifications of biotechnological drug substances / drug products – related to the impurity profiles
These example specifications will be useful “take home messages” which will help the participants to define or to evaluate specifications in their daily work.
Stability Testing for Drug Substances and Drug Products:
Analytical methods that were not “stability-indicating” are frequently cited in FDA 483s and Warning Letters. This course will thus address how to set impurity limits for related substances and degradation products based on method capability and stability results.
This course is intended to provide information on different aspects of stability testing. The course will be opened by an overview of stability testing with a special focus on the ICH Guidelines. In the subsequent presentation, important aspects of stability testing for biologicals and throughout drug development are discussed. Another lecture focuses on stability testing for Drug Substances, followed by a talk on Drug Products. In a further presentation, the focus lies on the various aspects of submitting stability data. Finally, statistical considerations will be covered in another lecture.
Programm
Basic Principles for Setting of Release and Shelf-Life Specifications
- Some basic statistics: Distribution and Variation
- Variation and specifications
- Changes over time and shelf-life specification
- Process Capability
- Control strategy
- QbD or not to be
Current Regulatory Requirements for Setting Specifications (ICH Q6A)
- Regulatory overview
- Impact of pharmacopoeial provisions
- Setting specifications for active substances and finished products
- Justification of specifications
- Changes/variations
- Introduction to the requirements of risk assessment with focus on setting specifications for heavy metals
- How authorities will proceed in respect of submitting the required documentation for approved marketed products
Specifications of Biopharmaceuticals
- Overview of regulatory requirements
- Critical Quality attributes and Control Strategy
- Differences between NCEs and NBEs
- Considerations for Drug Substance and Drug Product
- Specifications during early and late stage development
- Acceptance criteria at release and for shelf-life
Organic Impurities and Degradation Products with Special Emphasis on Genotoxic Impurities
- What do the guidelines tell us?
- Impurity identification and profiling
- Impurity tracking
- Toxicological qualification
- Genotoxic impurities
- Control of genotoxic impurities
Setting Specifications throughout Drug Development
- Specifications throughout development
- Specifications in Pharmacopoeias
- Stability of the manufacturing process
- Specifications for comparator products
Setting Specifications in the CTD
- Total Control Strategy and Regulatory Background
- Drug Substances, Excipients and Drug Products
- Packaging materials
- Which information should be included in the CTD
- Typical questions from authorities and answers
Specifications for Specific Drug Products – What is the Difference to Standard Formulations
- Specific aspects required for special drug products, e.g.
- Gastro-intestinal therapeutic systems (GITS) or osmotic-controlled release oral delivery systems (OROS)
- Transdermal Patches
- Orally inhaled and nasal drug products (OINDPs)
Parallel Session A (Lectures and Workshops)
CHEMICAL APIs
Group I: APIs Manufactured by Chemical Synthesis
Lecture and Workshop
Rational Development and Justification of API Specfications
- In this workshop participants will elaborate specifications comprising typical tests for APIs:
- Assay, organic impurities and degradation products, water, residual solvents, heavy metals, particle size distribution, polymorphs, genotoxic impurities etc.
BIOLOGICALS
Group II: Drug Substances/Drug Products Manufactured by Biotechnological Processes – Part 1
Group II: Drug Substances/Drug Products Manufactured by Biotechnological Processes – Part 1
Lecture and Workshop
Setting Specifications in early Biopharmaceutical Drug Development (with a special focus on Monoclonal Antibodies)
- General overview of manufacturing processes for biopharmaceuticals and process Control
- Analytical testing scope for biopharmaceuticals
- How to set specifications: principles to consider and justification
- Group Work
Parallel Session B (Lectures and Workshops)
DRUG PRODUCTS
Group I: Drug Products Containing APIs (manufactured by chemical synthesis)
Lecture and Workshop
Rational Development and Justification of Drug Products Specifications
- In this workshop participants will elaborate specifications comprising typical tests for different types of drug products, e.g. assay, purity, content uniformity, dissolution, fill volume, endotoxines, sterility etc.
BIOLOGICALS
Group II: Drug Substances/Drug Products Manufactured by Biotechnological Processes – Part 2
Group II: Drug Substances/Drug Products Manufactured by Biotechnological Processes – Part 2
Lecture and Workshop
Impurities in Biological Drug Substances and Drug Products (with a special focus on Monoclonal Antibodies)
- Impurities from chemical synthesis versus biotechnological process
- Definition of impurities and their classification: productrelated impurities, process-related impurities, contaminants and identification of possible degradation products
- How to deal with impurities in biological drug substances and drug products
- Analytical techniques and other aspects
*********************************
Current ICH and CHMP Guidelines for Stability Testing
- Overview of Stability Guidelines
- Concepts of Stability Testing
- Retest period and Shelf-life
- Post-marketing Stability Studies
- Future cctivities
Stability Testing for Biologicals
- Overview of regulatory requirements
- Types of stability studies for Biopharmaceuticals
- Practical aspects of stability studies with Biopharmaceuticals
- Degradation pathways
- Setting shelf-life during early and late stage development
Stability Testing throughout Drug Development
- Must the development stability programme meet ICH Q1A?
- Stability testing from early development to product launch
- Clinical stability for comparators
- Site-specific stability
Stability Testing for Drug Substances
- Stability protocols
- Stress testing
- Photostability testing
- Documentation
Stability Testing for Drug Products
- Strategy of Stability Testing
- Performance of new Drug Products
- Related Finished Products with existing substances
- Follow-up Stability Testing
Submitting Stability Data
- Regulatory Strategy Stability
- Drug Substance and Drug Product Stability Data and Evaluation
- Storage recommendations/labelling/SmPC
- Stability studies, commitments post approval
- Typical questions from authorities and answers
Evaluation of Stability Results – Statistical Considerations
- Sample number and replication
- Trend analysis
- Outliers
- Pooling of batch data
- Shelf-life prediction
Weitere Informationen
Venue
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona
Spain
+34 (93) 503 53 00
sants@barcelo.com
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona
Spain
+34 (93) 503 53 00
sants@barcelo.com
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
CONCEPT HEIDELBERG has reserved a limited number of rooms. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT)
Non-ECA Members € 2,990
ECA Members € 2,790
APIC Members € 2,890
EU GMP Inspectorates € 1,495
The conference fee is payable in advance after receipt of invoice and includes lunch and dinner on the first and second day, lunch on the third day and all refreshments. VAT is reclaimable.
Non-ECA Members € 2,990
ECA Members € 2,790
APIC Members € 2,890
EU GMP Inspectorates € 1,495
The conference fee is payable in advance after receipt of invoice and includes lunch and dinner on the first and second day, lunch on the third day and all refreshments. VAT is reclaimable.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
The official conference language will be English.
Contacts
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Marion Grimm, +49 (0)6221 84 44 18, grimm@concept-heidelberg.de
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Marion Grimm, +49 (0)6221 84 44 18, grimm@concept-heidelberg.de
Datum & Uhrzeiten
Setting Specifications and Acceptance Criteria:
Tue, 03 Nov 2026, 09:00-18:00 h
(Registration and coffee 08:30-09:00 h)
Wed, 04 Nov 2026, 08:30-14:00 h
(Lunch from 13:00-14:00 h)
Tue, 03 Nov 2026, 09:00-18:00 h
(Registration and coffee 08:30-09:00 h)
Wed, 04 Nov 2026, 08:30-14:00 h
(Lunch from 13:00-14:00 h)
Stability Testing for Drug Substances and Drug Products:
Wed, 04 Nov 2026, 14:00-18:00 h
(Registration and snack 13:30-14:00 h)
Thu, 05 Nov 2026, 08:30-15:00 h
Wed, 04 Nov 2026, 14:00-18:00 h
(Registration and snack 13:30-14:00 h)
Thu, 05 Nov 2026, 08:30-15:00 h
Teilnahmegebühr
| ECA-Member*: | € 2790,- |
| Non ECA Member*: | € 2990,- |
| EU/GMP Inspectorates*: | € 1495,- |
| APIC Member Discount*: | € 2890,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager"
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E-Mail: info@concept-heidelberg.de
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